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NCT07690540Recruiting

DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER

INVESTIGATING DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER: A MULTIDIMENSIONAL APPROACH IN A UNIQUE POPULATION (iDEA PROJECT)

Source: ClinicalTrials.gov · Last updated 8 Jul 2026

Brief summary (registry, in English)

In recent years, the introduction of immune checkpoint inhibitors (ICI) in combination with chemotherapy has significantly changed the management of advanced and recurrent Endometrial Cancer (EC). Despite these advances, responses to immunotherapy remain heterogeneous. Not all patients with mismatch repair-deficient (dMMR) tumors derive durable benefit, while a subset of mismatch repair-proficient (pMMR) tumors may respond. In addition, ICI treatment is associated with relevant costs and immune-related toxicities, highlighting the need for improved patient selection. To date, no validated predictive biomarkers beyond mismatch repair (MMR) status are available, reflecting limited understanding of the biological mechanisms underlying sensitivity and resistance to immunotherapy in EC. This study aims to assess and integrate molecular and epigenetic features to identify prognostic and predictive biomarkers of immunotherapy response in endometrial cancer, and to explore their functional relevance using patient-derived experimental models.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
510 (estimated)
First submitted
2 Jul 2026
Start date
14 Apr 2026
Primary completion date
30 Apr 2029
Lead sponsor
European Institute of Oncology
NCT number
NCT07690540

What you commit to

  • Study type: Interventional
  • Planned participants: 510
  • From 14 Apr 2026 to the primary completion date, 30 Apr 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Active treatment with immunomodulatory agents at the time of sample collection (e.g., immunotherapy for autoimmune disease)

Other illness

  • Mesenchymal tumors or epithelial tumors of non-endometrial origin (e.g., ovarian cancer)
  • Known positivity for HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)

Other

  • Refusal or inability to provide informed consent by the patient or legal representative

Who the study is looking for

  • Age ≥ 18 years
  • Histologically confirmed advanced or recurrent endometrial carcinoma or carcinosarcoma
  • No prior treatment with immune checkpoint inhibitors
  • Availability of paired fresh-frozen and FFPE tumor samples
  • Provision of written informed consent for participation in translational research

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
European Institute of Oncology
Coordinator of this site? Confirm its status
MilanItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.